MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_NAVISTAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pseudoaneurysm (2605); No Code Available (3191)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Biosense webster manufacturer's report numbers: 2029046-2020-00611 is related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿combined use of electro-anatomic mapping system and intracardiac echocardiography to achieve zero-fluoroscopy catheter ablation for treatment of paroxysmal atrial fibrillation: a single-center experience¿ 2 patients with atrial fibrillation (af) who underwent catheter ablation (ca) experienced pseudoaneurysm of the femoral artery that required surgical intervention.Objectives: the safety and efficacy of zero-fluoroscopy catheter ablation (ca) of paroxysmal atrial fibrillation (af) with combined use of electroanatomic mapping system (eam) and intracardiac echocardiography (ice).Methods:144 consecutive patients between july 2016 and august 2018 with the indication to undergo ca for symptomatic paroxysmal af were reviewed.

• Brand Name: UNK_NAVISTAR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10065975
• MDR Text Key: 193430281
• Report Number: 2029046-2020-00610
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR